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Regulations and Compliance

Chapter

Regulations and Compliance

Learning Objectives
1

Learners understand the legal foundation for medical device regulation in Portugal.

2

Learners understand the process of securing regulatory approval.

3

Learners acknowledge responsibilities as a manufacturer.

4

Learners have awareness of key stakeholder organisations involved.

5

Learners know where to look to find more information on key areas.

6

Learners understand how a medical device is regulated.

Component

Major steps and support for acquiring the CE Marking on a Medical Device or Diagnostic

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Component

European Union Wide Marketing Authorisation

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Component

Regulatory Requirements for Marketing Authorisation

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Component

The Basis for Regulation of Medical Devices in Portugal

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